SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--VistaGen Therapeutics, Inc., a stem cell technology company focused on
drug discovery and development, today announced the successful
completion of its initial Phase 1 safety study of AV-101, the Company’s
novel orally available prodrug candidate for treatment of neuropathic
pain. Neuropathic pain, a serious and chronic condition causing pain
after an injury or disease of the peripheral or central nervous system,
affects approximately 1.8 million people in the U.S.

“This successful initial human safety study is an important first step
towards our goal of developing AV-101 for several large market
neurological diseases and disorders, including not only neuropathic pain
but also epilepsy, Huntington’s disease and Parkinson’s disease,” said
Shawn K. Singh, JD, VistaGen’s Chief Executive Officer. “We are grateful
for the substantial financial support we have received for our AV-101
program from the U.S. National Institutes of Health, as well as the
world class regulatory and development assistance we have received from
Cato Research Ltd. With that ongoing support and assistance, we now
expect to complete our second AV-101 Phase 1 safety study during the
first quarter of 2011.”

About the Study

VistaGen’s initial AV-101 Phase 1 clinical trial was a randomized,
double-blind, placebo-controlled study designed to evaluate the safety
and pharmacokinetics of single doses of AV-101 in two cohorts of healthy
volunteers. AV-101 was well-tolerated by all subjects, had good
bioavailability and did not cause any serious adverse events.

About AV-101

Aimed at the multi-billion dollar neurological disease and disorders
market, AV-101, also known as “L-4-chlorokynurenine” and “4-Cl-KYN”, is
a novel, orally available prodrug that is converted in the brain into an
active metabolite, 7-chlorokynurenic acid (7-CI-KYNA), which regulates
an important neurotransmitter in the brain called the
N-methyl-D-aspartate (or NMDA) receptor. 7-CI-KYNA is a synthetic
analogue of kynurenic acid, which is a naturally occurring neural
regulatory compound and one of the most potent and selective blockers of
the regulatory GlyB-site of the NMDA receptor.

VistaGen’s current AV-101 IND application covers clinical development
for neuropathic pain. VistaGen expects its AV-101 Phase I clinical
program for neuropathic pain to support the development of the drug
candidate for neurological disorders, such as epilepsy, and
neurodegenerative diseases, such as Huntington’s and Parkinson’s.

To date, the U.S. National Institutes of Health (NIH) has awarded
VistaGen over $8.75 million for development of AV-101.

About VistaGen Therapeutics

VistaGen Therapeutics is a biotechnology company focused on using
proprietary pluripotent stem cell technology to discover, rescue and
develop novel drug candidates for a broad range of diseases and
conditions. VistaGen’s integrated stem cell technology platform,
Human Clinical Trials in a Test Tube™, is based on the
differentiation of human pluripotent stem cells into multiple types of
mature cells which can then be used in new generation assay systems for
predictive toxicology, as well as drug discovery, rescue and
development. VistaGen uses its pluripotent stem cell technology to
generate early indications, or predictions, of how humans will
ultimately respond to new drug candidates long before they are ever
tested in humans. VistaGen’s drug rescue activities are directed at
creating new chemical variants of promising drug candidates that
pharmaceutical companies have put on the shelf (discontinued in
development) due to toxicity concerns, despite positive efficacy data
demonstrating their potential therapeutic benefits. VistaGen’s goal is
to develop a broad pipeline of drug rescue variants (proprietary new
small molecule drug candidates) that will be as effective as the
original drug candidates discontinued in development by others due to
toxicity concerns but without the toxicity that caused them to be put on
the shelf. VistaGen expects its pluripotent stem cell-based biological
assays and screening systems to help discover, validate, prioritize,
rescue and develop novel drug candidates with greater flexibility, speed
and efficiency compared to traditional techniques currently used in the
pharmaceutical industry.